Back to resultsPA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Primary Purpose
Chronic Kidney Disease Requiring Hemodialysis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
PA21
PA21
PA21
PA21
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Requiring Hemodialysis focused on measuring Hemodialysis, Hyperphosphatemia
Eligibility Criteria
Inclusion Criteria:
- Patients age 20 or older, regardless of gender.
- Receiving stable maintenance hemodialysis 3 times a week.
- Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
Exclusion Criteria:
- Patients having history of a pronounced brain / cardiovascular disorder.
- Patients having severe gastrointestinal disorders.
- Patients having severe hepatic disorders.
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
PA21 750 mg/day
PA21 1500 mg/day
PA21 2250 mg/day
PA21 3000 mg/day
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Secondary Outcome Measures
Change From Baseline in Serum Calcium Concentrations.
Change From Baseline in Serum Intact-PTH Concentrations.
Full Information
NCT ID
NCT01521494
First Posted
January 26, 2012
Last Updated
November 27, 2017
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01521494
Brief Title
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 11, 2012 (Actual)
Primary Completion Date
July 3, 2012 (Actual)
Study Completion Date
July 3, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Hemodialysis
Keywords
Hemodialysis, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PA21 750 mg/day
Arm Type
Experimental
Arm Title
PA21 1500 mg/day
Arm Type
Experimental
Arm Title
PA21 2250 mg/day
Arm Type
Experimental
Arm Title
PA21 3000 mg/day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PA21
Intervention Type
Drug
Intervention Name(s)
PA21
Intervention Type
Drug
Intervention Name(s)
PA21
Intervention Type
Drug
Intervention Name(s)
PA21
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Description
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum Calcium Concentrations.
Time Frame
6 weeks
Title
Change From Baseline in Serum Intact-PTH Concentrations.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age 20 or older, regardless of gender.
Receiving stable maintenance hemodialysis 3 times a week.
Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
Exclusion Criteria:
Patients having history of a pronounced brain / cardiovascular disorder.
Patients having severe gastrointestinal disorders.
Patients having severe hepatic disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuro Takei
Organizational Affiliation
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
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